DementiaIN-TX-PPCNCT06001775
Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
A study testing Patient Priorities Care in people with Dementia and Mild Cognitive Impairment, run by Indiana University at 3 sites in United States.
Trial summary
The goal of this pragmatic, embedded clinical trial is to analyze the implementation of Patient Priorities Care in primary care and geriatrics clinics with patients living with dementia or mild cognitive impairment. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Dementia, Mild Cognitive Impairment
- What is being tested?
- Patient Priorities Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Aug 2023to 15 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Inclusion Criteria
- Patients must meet all of the following criteria to participate in this study:
- 40 years or older
- English-speaking at both Indiana sites or English and/or Spanish speaking at the University of Texas site
- Receiving care with a participating physician
- Has a scheduled outpatient care visit within 1-2 months (60 days)
Show all 14Show fewer
- Individual has a diagnosis of MCI or dementia
- Definition: To identify individuals with dementia and MCI, we will use two or more instances of use of an ICD-10 code for either diagnosis in the EHR within 24 months. Typically, we would include instances of these billing codes within a year of each other but, due to the COVID-19 pandemic, recognize that there may be less frequent clinical visits and less robust billing. Diagnostic codes include:
- F01.50, F01.51, F02.80, F02.81, F03.90, G30.0, G30.1, G30.8, G30.9, G31.01, G31.09, G31.1, G31.2, F41.81, G31.84 and F03.91.
- Care Partner Inclusion Criteria
- Care partners must meet all of the following criteria to participate in the study:
- 18 years or older
- English-speaking at both Indiana sites or English and/or Spanish speaking at the University of Texas site
- A note about inclusion of care partners: Clinician determination of a patient's capacity to participate in a visit independently is part of a pragmatic approach. This means that clinic staff will determine when a care partner is needed. Generally, we act under the assumption that patients who require a care partner will have already included them in previous visits and/or provider communications (and we anticipate that this will be documented in the EHR), whereas patients who attend clinic visits independently and have no documentation indicating the involvement of a care partner in their medical decisions, or a need for one, will be determined to have the capacity to also participate in a PPC visit.
Who cannot join
- Participants who meet any of the following criteria will be excluded from the study:
- Is not community-dwelling- e.g. lives in a nursing home
- Is enrolled in hospice
- Individuals who decline to receive the PPC intervention (i.e. decline to have the PPC conversation) will be excluded from the study.
- Note that declining to receive the PPC intervention will in no way impact the care that patients receive now or in the future.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Health- Houston
Houston, Texas, 77030
Eskenazi Health
Indianapolis, Indiana, 46202
Indiana University Health Connected Care
Indianapolis, Indiana, 46219
About this study
Official title: Embedded Clinical Trial of Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
The goal of this pragmatic, embedded clinical trial is to analyze the implementation of Patient Priorities Care in primary care and geriatrics clinics with patients living with dementia or mild cognitive impairment. This study aims are:
- demonstrate the feasibility of using the electronic health record to identify a diverse cohort of eligible patients who will engage in a Patient Priorities Care conversation with a trained facilitator.
- demonstrate feasibility of pragmatically assessing clinical outcomes using the electronic health record, including a) number of days at home, b) total medications, and c) new referrals to specialist physicians.
- examine key feasibility measures across racial, ethnic, and socioeconomic subgroups.
Participants will receive a packet of information about Patient Priorities Care from their primary care clinic, in advance of their next upcoming clinic appointment. Individuals who receive a packet will have the opportunity to engage in a conversation about what matters most to them and what their priorities are, with trained facilitators at the clinic.
- Conditions
- Dementia, Mild Cognitive Impairment
- Being tested
- Patient Priorities Care
- Keywords
- dementia, mild cognitive impairment, patient priorities care
- Medical subject headings
- Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Priorities CareBehavioural
According to patientprioritiescare.org a Patient Priorities Care conversation helps to align healthcare decision-making and care by all clinicians with patients' own health priorities. Patient Priorities Care involves not only the health outcome goals that patients want to achieve, but also their preferences for healthcare.
| Study group | Role | What they receive |
|---|---|---|
| Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment | Experimental | Patients will receive a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) will initiate a Patient Priorities Care conversation with the patient. This conversation will be documented in the Electronic Health Record. Receives: Behavioral: Patient Priorities Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of PPC Discussion
Review of the electronic health record will be used to assess for the presence of documentation of patient priorities care for each enrolled patient. Documentation can occur from enrollment through enrolled patient's visit with the participating physician in clinic. Enrollment (mailing of packet) occurred from two months prior to scheduled appointment with participating physician to clinic appointment. Documentation of discussion could occur from two months prior up to within 24 hours of clinic appointment with participating physician.
Measured: From enrollment to participating clinic visit
Secondary outcomes (12)
Identification of a Care Partner
Identification of a care partner for 50% of eligible persons living with dementia and mild cognitive impairment. Care partners will be identified based on information provided by the patient, the electronic health record, and the clinical team.
Measured: Baseline and up to 2 months post baseline
Acceptability
Acceptability will be assessed using Sekhon's Theoretical Framework of Acceptability (TFA) to qualitatively assess acceptability, which includes meeting definitions outlined within the framework, represented by seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy.
Measured: Baseline and up to 2 months post baseline
Appropriateness
Appropriateness will be assessed via qualitative exit interviews with patients, care partners, and clinicians.
Measured: Baseline and up to 2 months post baseline
Feasibility of the Intervention
Feasibility will be assessed qualitatively using the description provided by Proctor et al as a guide.
Measured: Baseline and up to 2 months post baseline
Fidelity to the Intervention
Fidelity will be assessed when select charts are reviewed for adherence to the protocol.
Measured: Baseline and up to 2 months post baseline
Potential for Future Adoption of Patient Priorities Care Intervention
Assessment of potential for future adoption of the intervention will be conducted via qualitative exit interviews with patients, care partners, and clinicians.
Measured: Baseline and up to 2 months post baseline
Number of Patient Days at Home
Review of the electronic health record will be used to assess for hospital visits, emergency room visits, or nursing home admissions. Number of patient days at home will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences.
Measured: 2 months pre and 2 months post baseline
Number of Total Medications
Review of the electronic health record will be used to assess the medication list total at 2 months pre and post baseline. Number of total medications will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences.
Measured: 2 months pre and 2 months post baseline
Number of New Referrals to Specialist Physicians
Review of the electronic health record to identify the number of referrals to specialists at 2 months pre and post baseline. Number of new referrals to specialist physicians will be further evaluated across racial, ethnic, and socioeconomic subgroups to detect any differences.
Measured: 2 months pre and 2 months post baseline
Number of Patients Across Racial, Ethnic, and Socioeconomic Subgroups With Documentation of Patient Priorities Care Discussion in the Electronic Health Record
Evaluation will occur using a previously established natural language processing model to identify patient medical records when a Patient Priorities Care discussion is recorded.
Measured: 2 months pre and 2 months post baseline
Acceptability Across Racial, Ethnic, and Socioeconomic Subgroups.
Acceptability effects will be further evaluated across racial, ethnic, and socioeconomic subgroups. We will utilize Sekhon et al's Theoretical Framework of Acceptability (TFA) to qualitatively assess acceptability, which includes meeting definitions outlined within the framework, represented by seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy.
Measured: Baseline and up to 2 months post baseline
Number of Patients With Social Factors Indicated in the Electronic Health Record
Established algorithms for detecting social factors that may influence patient care priorities, such as housing instability, financial insecurity, or transportation concerns will be deployed. These algorithms have been previously created and validated across the care spectrum and will be deployed at the primary site in current form on the established natural language processing platform at Regenstrief Institute. Similar data will be manually extracted using keywords from the primary site for the secondary site. All available clinical notes for the recruited cohort will be annotated by the software as either positive or negative for the social factors. This can then be incorporated into analyses.
Measured: Baseline and up to 2 months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start31 Aug 2023
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Jennifer L Carnahan, Indiana University
- Investigators
- Katie Allen, PhD, Principal investigator, Regenstrief Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001775
- Sponsor's protocol ID
- FY22_Pilot1_Carnahan
- Other IDs
- 15345, Pro00063400, U54AG063546
- Acronym
- IN-TX-PPC
- Status last verified
- Feb 2026
- First submitted
- 7 Aug 2023
- Last updated
- 2 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this study is a pragmatic trial in a clinical environment, the majority of our outcomes will be determined via data that is already held in the EHR. Therefore a plan for sharing IPD seems unnecessary.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embedded Clinical Trial of Patient Priorities Care Among Persons Living With Mild Cognitive Impairment and Dementia
- ClinicalTrials.gov ID
- NCT06001775
- Acronym / sponsor ID
- IN-TX-PPC / FY22_Pilot1_Carnahan
- Conditions
- Dementia, Mild Cognitive Impairment
- Keywords
- dementia, mild cognitive impairment, patient priorities care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pragmatic, embedded clinical trial is to analyze the implementation of Patient Priorities Care in primary care and geriatrics clinics with patients living with dementia or mild cognitive impairment. This study aims are:
- demonstrate the feasibility of using the electronic health record to identify a diverse cohort of eligible patients who will engage in a Patient Priorities Care conversation with a trained facilitator.
- demonstrate feasibility of pragmatically assessing clinical outcomes using the electronic health record, including a) number of days at home, b) total medications, and c) new referrals to specialist physicians.
- examine key feasibility measures across racial, ethnic, and socioeconomic subgroups.
Participants will receive a packet of information about Patient Priorities Care from their primary care clinic, in advance of their next upcoming clinic appointment. Individuals who receive a packet will have the opportunity to engage in a conversation about what matters most to them and what their priorities are, with trained facilitators at the clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment | Experimental | Behavioral: Patient Priorities CarePatients will receive a packet of information about Patient Priorities Care, and when feasible, a trained facilitator(s) will initiate a Patient Priorities Care conversation with the patient. This conversation will be documented in the Electronic Health Record. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient Inclusion Criteria
- 40 years or older
- Definition: To identify individuals with dementia and MCI, we will use two or more instances of use of an ICD-10 code for either diagnosis in the EHR within 24 months. Typically, we would include instances of these billing codes within a year of each other but, due to the COVID-19 pandemic, recognize that there may be less frequent clinical visits and less robust billing. Diagnostic codes include:
- F01.50, F01.51, F02.80, F02.81, F03.90, G30.0, G30.1, G30.8, G30.9, G31.01, G31.09, G31.1, G31.2, F41.81, G31.84 and F03.91.
- Care Partner Inclusion Criteria
Key exclusion criteria (5 listed)
- Is not community-dwelling- e.g. lives in a nursing home
- Is enrolled in hospice
- Individuals who decline to receive the PPC intervention (i.e. decline to have the PPC conversation) will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Priorities CareAccording to patientprioritiescare.org a Patient Priorities Care conversation helps to align healthcare decision-making and care by all clinicians with patients' own health priorities. Patient Priorities Care involves not only the health outcome goals that patients want to achieve, but also their preferences for healthcare. | Behavioural | Patient Priorities Care Eligible Persons Living With Dementia and Mild Cognitive Impairment |
Primary outcome
Documentation of PPC Discussion
Time frame: From enrollment to participating clinic visit
Review of the electronic health record will be used to assess for the presence of documentation of patient priorities care for each enrolled patient. Documentation can occur from enrollment through enrolled patient's visit with the participating physician in clinic. Enrollment (mailing of packet) occurred from two months prior to scheduled appointment with participating physician to clinic appointment. Documentation of discussion could occur from two months prior up to within 24 hours of clinic appointment with participating physician.
12 secondary outcomes
Identification of a Care Partner
Time frame: Baseline and up to 2 months post baseline
Acceptability
Time frame: Baseline and up to 2 months post baseline
Appropriateness
Time frame: Baseline and up to 2 months post baseline
Feasibility of the Intervention
Time frame: Baseline and up to 2 months post baseline
Fidelity to the Intervention
Time frame: Baseline and up to 2 months post baseline
Potential for Future Adoption of Patient Priorities Care Intervention
Time frame: Baseline and up to 2 months post baseline
Number of Patient Days at Home
Time frame: 2 months pre and 2 months post baseline
Number of Total Medications
Time frame: 2 months pre and 2 months post baseline
Number of New Referrals to Specialist Physicians
Time frame: 2 months pre and 2 months post baseline
Number of Patients Across Racial, Ethnic, and Socioeconomic Subgroups With Documentation of Patient Priorities Care Discussion in the Electronic Health Record
Time frame: 2 months pre and 2 months post baseline
Acceptability Across Racial, Ethnic, and Socioeconomic Subgroups.
Time frame: Baseline and up to 2 months post baseline
Number of Patients With Social Factors Indicated in the Electronic Health Record
Time frame: Baseline and up to 2 months post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Patient Priorities Care homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Since this study is a pragmatic trial in a clinical environment, the majority of our outcomes will be determined via data that is already held in the EHR. Therefore a plan for sharing IPD seems unnecessary.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Allen, PhD principal investigator
Regenstrief Institute, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Priorities Care in people with Dementia and Mild Cognitive Impairment, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of PPC Discussion (time frame: From enrollment to participating clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.